Kornimate/medical-research-clean huggingface dataset:
a study of ac676 for the treatment of relapsed/refractory b-cell malignancies

Conditions: Relapsed/Refractory B-cell Malignancies

Summary: this clinical trial is evaluating a drug called ac676 in participants with relapsed/refractory b-cell malignancies. the main goals of the study are to: * identify the recommended dose of ac676 that can be given safely to participants * evaluate the safety profile of ac676 * evaluate the pharmacokinetics of ac676 * evaluate the effectiveness of ac676

ac676-001 is a phase i, first-in-human, open-label, multi-center dose-escalation study of ac676 given as a single agent. ac676 is an investigational medicinal product that is an orally bioavailable btk degrader for the treatment of b-cell malignancies.

Eligibility criteria:
inclusion criteria: 1. adult male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (icf). 2. patients with histologically confirmed relapsed/refractory chronic lymphocytic leukemia (cll), small lymphocytic lymphoma (sll), mantle cell lymphoma (mcl), follicular lymphoma (fl), non-gcb diffuse large b-cell lymphoma (dlbcl), marginal zone lymphoma (mzl), or waldenström macroglobulinemia (wm). 3. must have received at least 2 prior systemic therapies or have no other therapies to provide significant clinical benefit in the opinion of the investigator or who are not amenable (intolerability, patient choice) to standard therapies. exclusion criteria: patients who meet any of the following criteria will be excluded from study entry: 1. treatment with any of the following: * small molecule anti-cancer drugs within 5 half-lives or 2 days (whichever is longer, not to exceed 14 days). * systemic chemotherapy within 14 days. * radiation therapy within 14 days * biologics (antibodies) treatment within 28 days, * radioimmunoconjugates or toxin conjugates within 12 weeks. * prior chimeric antigen receptor (car) t cell therapy (and prior use of immunoglobulin replacement therapy to treat associated adverse events) within 3 months. for patients with dlbcl, no prior car- t therapy is allowed. * autologous or allogenic stem cell transplant within 100 days and must not have ongoing graft-versus-host disease (gvhd) and no ongoing therapy to treat gvhd. 2. history of central nervous system lymphoma/leukemia in remission for less than 2 years. 3. medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.

Keywords: chronic lymphocytic leukemia (cll) small lymphocytic lymphoma (sll) mantle cell lymphoma (mcl) follicular lymphoma (fl) non-germinal center b-cell (non-gcb) diffuse large b-cell lymphoma (dlbcl) marginal zone lymphoma (mzl waldenström macroglobulinemia (wm) non-hodgkin lymphoma (nhl) bruton's tyrosine kinase-btk btk degrader ac676 ac0676
study of human insulin inhalation powder in patients with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: this is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the lilly/alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. patients will be treated for 24 months with a 2-month follow-up period.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * non smoker * normal lung function exclusion criteria: * significant pulmonary, hepatic, or renal disease * severe congestive heart failure * active malignancy * systemic glucocorticoid therapy
foley catheter vs a self-contained valved urinary catheter

Conditions: Catheter-Related Infections; Urinary Tract Infections; Urogynecologic Surgery

Summary: the purpose of this study is to compare uti rates and patient satisfaction associated with indwelling foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a randomized clinical trial.

the purpose of this study is to compare uti rates and patient satisfaction associated with indwelling foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a randomized clinical trial. total number of participants will be 100. inclusion criteria is all patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter. exclusion criteria is intra-operative bladder injury during index surgery; intra-operative complication requiring continuous bladder drainage; and/or dementia/altered cognitive function.

Eligibility criteria:
inclusion criteria: all patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter. exclusion criteria: * intra-operative bladder injury during index surgery * intra-operative complication requiring continuous bladder drainage * dementia / altered cognitive function
adjuvant cisplatin and docetaxel in non small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: * to determine if docetaxel and cisplatin can be administered in a dose intense manner in the adjuvant setting in resected non-small cell lung cancer * to evaluate the time to progression and overall survival * to evaluate toxicities of this chemotherapy combination in the adjuvant setting * to correlate xpd and ercc1 polymorphisms with time to progression and toxicities in patients treated with this regimen


Eligibility criteria:
inclusion criteria: * stage ib to iiia non-small cell lung cancer completely resected within 4 to 8 weeks of initiating treatment on study * performance status ecog 0 or 1 * peripheral neuropathy: \< grade 1 * adequate blood cell counts * adequate liver and hepatic function * women of childbearing potential must have a negative pregnancy test. * men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter exclusion criteria: * patients with a history of severe hypersensitivity reaction to docetaxel® or other drugs formulated with polysorbate 80. * women who are breast-feeding. * coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively) * uncontrolled cardiac disease or uncontrolled hypertension

Keywords: non small cell lung cancer adjuvant cisplatin docetaxel
mechanisms of immune reconstitution & reduced immune activation following darunavir-based art

Conditions: Human Immunodeficiency Virus Infection

Summary: potent hiv suppression with darunavir-based antiretroviral therapy (art) will lead to repopulation of gastrointestinal-associated lymphoid tissue (galt) cluster of differentiation (cd)4+ t-cell populations, normalization of systemic immune activation, and improved hiv-associated cardiovascular disease (cvd) risk.

rationale infection with hiv causes significant morbidity and mortality, even among individuals who are virologically suppressed with combination anti-retroviral therapy (art). art is effective in prolonging life and enabling individuals who are hiv positive to live near-normal life spans. however, these individuals are increasingly developing a number of chronic diseases of aging, such as atherosclerotic cardiovascular disease (ascvd). the proposed studies will examine the role of highly active antiretroviral therapy in restoring the mucosal immunity and the systemic effect on immune activation, bacterial translocation, and change in hiv-associated cardiovascular disease risk.

Eligibility criteria:
inclusion criteria: * willing to sign consent form * naïve to art (remote art use \>5 years will be considered on a case by case basis) * no known gi or cardiovascular disease * between the ages of 18 and 60 * no active opportunistic infections or therapy for acute oi within 30 days of entry. subjects can be on secondary prophylaxis with a history of aids defining illness. * all women of childbearing potential (wcbp) must have a negative urine pregnancy test before any of the invasive or radiation exposure study procedures. * normal population should be free of chronic metabolic conditions such as diabetes, hypercholesterolemia, or coronary artery disease * there are no cd4+ t-cell count or hiv plasma viral load restrictions. exclusion criteria: * abnormal coagulation parameters (pt\>1.2 upper limit of normal (uln)) * thrombocytopenia (platelet count \<50.000 within 6 weeks) * contra-indications to upper endoscopy or conscious sedation * anemia (\>grade 1 \[appendix 1\]) * aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy. * renal insufficiency (serum creatinine \>1.2 uln) * history of chronic proteinuria that could impact viread use. * allergy to contrast used for ct angiography * requirement to take medications that are contraindicated with study art regimen.

Keywords: hiv cardiovascular risk systemic immune activation
bracing during infantile scoliosis: airways study

Conditions: Scoliosis

Summary: idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may impact on the intrathoracic organs. bracing is one of the oldest treatments of spinal deformities. it relies on the indirect manipulation of spinal curvatures in order to prevent curve progression, which may affect respiratory function. the acoustic reflection method is based on the analysis of the reflection of a single transient planar wave giving the longitudinal cross-sectional area profile of the examined cavity. it is noninvasive and harmless. the eos™ device allows a double incidence, full body, and low-dose x-ray acquisition with thoracic 3d reconstruction. the aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the eos™)


Eligibility criteria:
inclusion criteria: * children with evolutive juvenile thoracic scoliosis * with a cobb angle ≥ 30° * requiring either a milwaukee or a cheneaux brace * in a stable respiratory state exclusion criteria: * history of spine surgery

Keywords: infantile scoliosis bracing acoustic reflection method eos™ noninvasive upper airways thoracic penetration index idiopathic juvenile evolutive thoracic scoliosis
combining pelvic floor rehabilitation with postural re-education in women with stress urinary incontinence and chronic low back pain: a preliminary study.

Conditions: Stress Urinary Incontinence; Low Back Pain

Summary: stress urinary incontinence (sui) is a common health condition in female population. although its prevalence increases with the age, women of all ages could be affected. several epidemiological studies have shown an association of sui with low back pain (lbp) demonstrating, moreover, that the presence of one condition may predispose the patient to the onset of the other. concerning the lbp, the clinical practice guidelines provided recommendations for physical rehabilitative treatment. different techniques and physical exercises have been developed and it is difficult at the date to affirm the superiority of one approach as compared to another. moreover, the crucial role plays by the pelvic floor muscles (pfm) both as an integral part of trunk and lumbo-pelvic stability and in maintenance of urinary continence, lead the pelvic floor muscles disfunction to be associated both with sui and lbp, making the pfm rehabilitation a useful approach in both the conditions. in this rehabilitative context the present study aims to verify the effectiveness of a global physical approach based on postural re-education combined to the pelvic floor rehabilitation in women with diagnosis of stress urinary incontinence associated with non-specific chronic low back pain.


Eligibility criteria:
inclusion criteria: * woman aged from 18 to 75 years; * diagnosis of stress urinary incontinence associated with non-specific chronic low back pain exclusion criteria: * severe pelvic organs prolapse (\>second stage following the international continence society (ics) classification); * pregnancy; * perineal denervation; * inverted perineal command; * presence of pelvic pain; * fecal incontinence; * vaginal infections; * associated pathologies involving the central nervous system (cns); * psychotic disorders
sero-conversion study for a two-dose schedule of sabin ipv in china

Conditions: Poliomyelitis

Summary: this study aims to obtain the direct domestic ipv vaccine monitoring data for the cnbg products, and provide scientific evidence for the national immunization program and long-term polio vaccine immunization policy. the overall objective of this research is to determine the seroconversion rates of two reduced sabin ipv schedules in chinese children - a 2-dose schedule and a 3-dose schedule.

in april 2017, who/sage recommended that a two-dose, ipv-only schedule can be used after polio eradication, with a schedule seroconversion target of at least 90%. the recommendation was based in part on a study conducted in cuba using salk-ipv at 4 months and 8 months of age. however, for domestic sabin ipvs, there are no such data to support a 2-dose schedule among chinese infants.two sabin ipv products that are available to china's national immunization program - produced by kunming bio institute and china national biotec group (cnbg).the monitoring study on sipv produced by kunming bio institute has already applied for approval.this study aims to obtain the direct domestic ipv vaccine monitoring data for the cnbg products, and provide scientific evidence for the national immunization program and long-term polio vaccine immunization policy. the overall objective of this research is to determine the seroconversion rates of two reduced sabin ipv schedules in chinese children - a 2-dose schedule and a 3-dose schedule. the specific objectives of the study are to: 1. determine whether the seroconversion rate is above 90% with a 2-dose sabin ipv schedule, with the first dose given at 4 months and the second dose given ≥4 months after the first dose. 2. measure neutralizing antibody titers against poliovirus type i, ii and iii among two-dose sabin ipv alone schedule, compared with three-dose sabin ipv alone schedule.

Eligibility criteria:
inclusion criteria: * parent or legal guardian agree to participate in our study. * the family is living locally with legal residency status. exclusion criteria: * parent or legal guardian does not agree to participate in our study. * the potential subject has received ipv or opv before 4 months of age in the two-dose schedule group. * the potential subject has one or more contraindications to ipv (although we will note the contraindications).

Keywords: inactivated poliovirus vaccine sabin strain
influence of thoracic outlet syndrome severity on upper extremity function and neural integrity

Conditions: Thoracic Outlet Syndrome

Summary: the purpose of this study is to investigate the relationship between the severity of thoracic outlet syndrome and upper extremity function, as well as neural integrity.


Eligibility criteria:
inclusion criteria: * age 18-65 years * diagnosed with thoracic outlet syndrome * willing and able to provide informed consent exclusion criteria: * history of upper extremity surgery unrelated to thoracic outlet syndrome * other upper extremity disorders unrelated to thoracic outlet syndrome
adjuvant ccrt vs ct in minimal n2 nsclc

Conditions: Non-small Cell Lung Cancer

Summary: this study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic n2 nsclc

approximately 15% of patients with non-small cell lung cancer are diagnosed with stage iiia-n2 disease. however, this subgroup is heterogeneous, with lymph nodes that are only microscopically invaded to those that are radiologically visible with bulky ipsilateral mediastinal lymph node involvement. surgical resection in selected patients results in 5-year survival rates of 7-24%. the standard treatment for locally advanced clinical n2 disease is definitive concurrent chemoradiotherapy or induction chemotherapy (± radiation) followed by operation. however, in some patients, n2 status could be confirmed only after curative operation without any evidence of n2 diseases through preoperative evaluation methods (ct, pet, mediastinoscopy). we usually define those n2 disease found only after curative operation as microscopic n2, and do adjuvant chemotherapy, radiotherapy or concurrent chemoradiotherapy. however, little data about the adjuvant therapy for completely resected n2 disease have been available, hence, we propose a randomized phase ii study of adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic n2 nsclc.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of stage iiia(n2) nsclc that was completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video-assisted thorascopic surgery approaches were acceptable) 2. "pathologic n2" disease (involvement of n2 nodes can only be determined at the time of surgical exploration or postoperative pathologic analysis) 3. age ≥18years 4. no known residual disease (negative resection margin and no extracapsular invasion of lymph node metastasis) 5. ecog performance status of 0 to 1 6. no previous chemotherapy or rt 7. adequate organ function as evidenced by the following; absolute neutrophil count \> 1.5 x 109/l; platelets \> 100 x 109/l; total bilirubin ≤1.5 unl; ast and/or alt \< 5 unl; creatinine clearance ≥ 50ml/min 8. written informed consent form exclusion criteria: 1. patients with preoperative mediastinoscopic n2 positive disease 2. uncontrolled systemic illness such as dm, chf, unstable angina, hypertension or arrhythmia 3. patients with post-obstructive pneumonia or uncontrolled serious infection 4. pregnant or nursing women ( women of reproductive potential have to agree to use an effective contraceptive method) 5. prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

Keywords: microscopic n2 non-small cell lung cancer paclitaxel carboplatin cisplatin
a phase 3 study in combination with bms-790052 and bms-650032 in japanese hepatitis c virus (hcv) patients

Conditions: Hepatitis C

Summary: the purpose of this study is to assess the anti-viral activity of bms-790052 and bms-650032 combination therapy in japanese subjects.


Eligibility criteria:
inclusion criteria: * chronic hcv-1b infected patient * hcv rna viral load of ≥ 100,000 iu/ml at screening * ages 20 to 75 years * non-responder to interferon plus ribavirin therapy * patient who has been excluded from interferon/ribavirin therapy or intolerant for interferon/ribavirin therapy exclusion criteria: patients who have - * hepatocellular carcinoma * co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * severe or uncontrollable complication

Keywords: hepatitis c virus infection
preemptive therapy with colchicine in patients older than 60 years with high risk of severe pneumoniae due to coronavirus

Conditions: SARS-CoV-2 Infection (COVID-19)

Summary: this is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus sars-cov2 (covid-19). an approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.

the primary objective of the study is to determine whether short term course of colchicines reduces number of deaths due to covid-19 and severe complications due to the virus in elderly patients with comorbidities. the secondary objective is to determine the safety of colchicines in this patient population. approximately 954 subjects who meet all inclusion criteria and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment (2:1 allocation ratio) during 21 days. follow-up assessments will occur every 48 hours and always at day 10, 21 and 61 following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.

Eligibility criteria:
inclusion criteria: 1. patients of both sexes who are at least 60 years old. 2. diagnosis of covid-19 infection in the last 72 hours and confirmed by pcr 3. patient in outpatient follow-up (not hospitalized or under consideration) or institutionalized in senior centers/residences 4. the patient must possess at least two of the following high-risk criteria 1. 60 years of age or older and 2. any of the following: diabetes mellitus, high blood pressure, known pulmonary disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, bicytopenia, pancytopenia, or the existence of simultaneous neutrophilia and lymphopenia 5. the patient must be able and willing to comply with the requirements of this study protocol. exclusion criteria: 1. hospitalized patient or under immediate consideration of doing so 2. patient taking colchicine for other indications 3. patient with history of allergic reaction or sensitivity to colchicine 4. patient with inflammatory bowel disease, gastric ulcer, chronic diarrhea or malabsorption 5. patient with pre-existing progressive neuromuscular disease 6. patient with kidney damage and estimated glomerular filtrate rate \<30 ml/m at 1732 7. patient undergoing chemotherapy for cancer, including haematological malignancies. 8. patients being treated with cyp3a4 and/or glycoprotein inhibitor drugs 9. immunosuppressive treatment 10. history of cirrhosis, chronic active hepatitis, severe chronic disease defined by got or gpt values exceeding 3 times the upper limit of normal. 11. if the investigator considers it, for any reason, to be an inadequate candidate. 12. patient and/or legal representative will not have signed the informed consent form.

Keywords: colchicine